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  2. Biologics license application - Wikipedia

    en.wikipedia.org/wiki/Biologics_License_Application

    A biologics license application (BLA) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680.

  3. Submission management system - Wikipedia

    en.wikipedia.org/wiki/Submission_management_system

    Submission management systems can be web-based system operating in a browser environment, a COTS based product, or may also be in the form of a desktop application. Submissions are completed electronically creating an efficient real-time process that saves time for both the submitter and recipient.

  4. Information disclosure statement - Wikipedia

    en.wikipedia.org/wiki/Information_disclosure...

    The information submitted in an IDS typically includes other issued patents, published patent applications, scientific journal articles, books, magazine articles, or any other published material that is relevant to the invention disclosed in the applicant's own patent application, irrespective of the country or language in which the published material was made.

  5. Software requirements specification - Wikipedia

    en.wikipedia.org/wiki/Software_requirements...

    A software requirements specification (SRS) is a description of a software system to be developed.It is modeled after the business requirements specification.The software requirements specification lays out functional and non-functional requirements, and it may include a set of use cases that describe user interactions that the software must provide to the user for perfect interaction.

  6. Requirements elicitation - Wikipedia

    en.wikipedia.org/wiki/Requirements_elicitation

    Before requirements can be analyzed, modeled, or specified they must be gathered through an elicitation process. Requirements elicitation is a part of the requirements engineering process, usually followed by analysis and specification of the requirements. Commonly used elicitation processes are the stakeholder meetings or interviews. [2]

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  9. Template:AfC submission/draft - Wikipedia

    en.wikipedia.org/wiki/Template:AFC_submission/draft

    This template is meant as a single template for marking the status of an Articles for creation submission. To use this template to submit an article for review, use {{subst:submit|username}}, where username is the username of the draft's creator (left blank it will assume it is you). The template uses one of the following parameter options:

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